Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Total hip or knee replacement is an important and cost-effective surgical intervention to relieve pain and improve independence and function in patients with osteoarthritis. The number of people waiting for elective surgeries has spiked in the COVID-19 pandemic. Prior to COVID-19, up to 40% of patients receiving joint replacement were frail and this number is rapidly increasing with longer wait-times and deconditioning associated with COVID-19 physical distancing. There is an urgent need to be responsive to the evolving challenges of healthcare. The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention before surgery will improve postsurgical outcomes for this population. The COVID-19 adapted hybrid model includes a multimodal frailty intervention that may be implemented either in person or virtually and is aligned with international consensus guidelines on frailty reduction. To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes. The investigators hypothesize the FitJoints multimodal frailty intervention, with exercise, nutrition and medication optimization, will reduce frailty and pain while improving function and quality of life. Building upon the success of the FitJoints feasibility study (n=69) in Hamilton, Ontario, in the proposed multi-site RCT (n=192), older adults (≥60 years) undergoing hip or knee joint replacement surgery who are frail will be randomized to either the 3 to 6-months of multimodal intervention or usual care until the date of their surgery at multiple sites (Hamilton Health Sciences \& St Joseph's Healthcare Hamilton, ON; London Health Science Centre, London, ON; Foothills Hospital, Calgary, AB),The FitJoints evidence-based, multimodal intervention includes a hybrid model that can be implemented either in person or virtually: 1. Physiotherapist supported multi-component exercise program 2. Nutrition and protein optimization including dietary counseling 3. Medication review with prescribing recommendations

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Pre-frail (score of 1 or 2) or frail (score of 3-5)

• ≥ 60 years old

• Receiving elective unilateral total hip or knee replacement

• Waiting time for surgery is estimated to be between 4 to 15 months

Locations
Other Locations
Canada
Foothill Medical Centre - Alberta Health Services
NOT_YET_RECRUITING
Calgary
Juravinski Hospital - Hamilton Health Sciences
RECRUITING
Hamilton
St. Joseph's Healthcare
NOT_YET_RECRUITING
Hamilton
University Hospital - London Health Sciences Centre
NOT_YET_RECRUITING
London
Contact Information
Primary
Alexandra Papaioannou, MD, MSc
papaioannou@hhsc.ca
(905) 521-2100
Backup
George Ioannidis, MSc, PhD
ioannidis@hhsc.ca
Time Frame
Start Date: 2022-06-14
Estimated Completion Date: 2026-03
Participants
Target number of participants: 192
Treatments
No_intervention: Usual Care
Participants in the control arm will receive usual care which involves patient education that all participants who are scheduled for hip/knee replacement receive at the arthroplasty centre. This may include recommendations to attend fitness classes or discuss nutrition tips and smoking cessation initiatives with their family doctor or other healthcare provider before surgery.
Active_comparator: FitJoints Multi-modal Intervention
Sponsors
Collaborators: Alberta Health services, Hamilton Health Sciences Corporation, St. Joseph's Health Care London, London Health Sciences Centre
Leads: McMaster University

This content was sourced from clinicaltrials.gov